Clinical Trial Submission Manager

You will direct the development, quality control and publication of submissions relating to asset development and registration, driving adherence to external regulatory guidelines and compliance timelines for multiple submission types. You will provide strategic direction to teams on regulatory logistics and serve as a regulatory operational liaison on the project team throughout the product lifecycle.

In this role, you will:
• Provide guidance, lead/co-lead projects, manage own time to meet objectives and plan resource requirements for projects across the department.
• Drive global submission management activities for the assigned assets, prepare, review and submit submissions to relevant stakeholders, in order to obtain all necessary authorizations/ approvals for the clinical trials.
• Coordinate submission production and assist with definition, development and implementation of global submissions policies and technologies to meet evolving business needs.
• Escalate, inform and resolve any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities.
• Promote the use of Document Management and Archival systems and standard document authoring, partnering with supplier groups as necessary in order to produce timely delivery of submission/archive ready components.
• Lead the interpretation of dossier requirements to produce business processes and ensure that those processes are implemented where appropriate at global and local level.
• Implement strategies that achieve operational excellence through interaction with global regulatory leaders and associated product teams.
• Support leadership to produce business processes by understanding regulatory guidelines and requirements.
• Make decisions to resolve moderately complex problems, develop new options, and operate independently in ambiguous situations

Work Location Assignment: Remote
דרישות התפקיד
:Here Is What You Need (Minimum Requirements)
•Bachelor’s Degree with 5+ years of experience
•Significant knowledge of the drug development process, Regulatory Affairs and submissions management.
•Understanding of systems and electronic technologies used to support submission and planning activities.
•Excellent written and verbal communication skills, with ability to communicate effectively with all levels of the organization.
•Strong analytical and problem-solving abilities.
•Advanced Microsoft Office Suite skills
•Demonstrated project management skills with the ability to manage multiple concurrent priorities.Bonus Points If You Have (Preferred Requirements)
• Advanced degree MA/MBS/M) and 3+ years experience, OR a PHD/PharmD/JD degree